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Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation

Primary Purpose

Chronic Constipation

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Prucalopride

About this trial

This is an interventional treatment trial for Chronic Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age.
Patient completed the entire treatment period of one of the following studies: PRU-USA-3, PRU-USA-11, PRU-USA-13, PRU-USA-21, PRU-USA-25, PRU-USA-27 or PRU-USA-28, or Patient participated in the re-treatment study PRU-USA-28 and did not qualify for Treatment period II after both washout periods.

Exclusion Criteria:

Patient with impaired renal function
Patient with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
Female of childbearing potential without adequate contraceptive protection during the study.
Patient who used an investigation drug other than prucalopride in the 30 days preceding the study.

Sites / Locations

Mayo Clinic

Outcomes

Primary Outcome Measures

Safety: adverse events, lab tests, vital signs, ECGs

Secondary Outcome Measures

Efficacy: PAC-QOL self-administered questionnaire, Patient's pattern of use of prucalopride

Pharmacokinetics: Prucalopride plasmaconcentrations

Full Information

NCT ID

NCT00987844

First Posted

September 24, 2009

Last Updated

September 30, 2009

Sponsor

Movetis

1. Study Identification

Unique Protocol Identification Number

NCT00987844

Brief Title

Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation

Official Title

A Study to Evaluate the Long-Term Tolerability, Safety, Patient Satisfaction, Pharmacokinetics, and Use Patterns of Oral Prucalopride Tablets in Patients With Chronic Constipation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

July 1998 (undefined)

Primary Completion Date

November 2000 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Movetis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Objectives: To evaluate the clinical long-term safety and the tolerability, patient satisfaction, pharmacokinetics and use of pattern of prucalopride given in doses up to 4 mg per day to patients with chronic constipation (CC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1775 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Prucalopride

Intervention Description

1 mg tablets, free dosing regiment with max. of 4 tablets o.d., treatment duration: up to 24 months

Primary Outcome Measure Information:

Title

Safety: adverse events, lab tests, vital signs, ECGs

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Efficacy: PAC-QOL self-administered questionnaire, Patient's pattern of use of prucalopride

Time Frame

24 months

Title

Pharmacokinetics: Prucalopride plasmaconcentrations

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age. Patient completed the entire treatment period of one of the following studies: PRU-USA-3, PRU-USA-11, PRU-USA-13, PRU-USA-21, PRU-USA-25, PRU-USA-27 or PRU-USA-28, or Patient participated in the re-treatment study PRU-USA-28 and did not qualify for Treatment period II after both washout periods. Exclusion Criteria: Patient with impaired renal function Patient with clinically significant abnormalities of haematology, urinalysis, or blood chemistry. Female of childbearing potential without adequate contraceptive protection during the study. Patient who used an investigation drug other than prucalopride in the 30 days preceding the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Camilleri, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21039673

Citation

Camilleri M, Van Outryve MJ, Beyens G, Kerstens R, Robinson P, Vandeplassche L. Clinical trial: the efficacy of open-label prucalopride treatment in patients with chronic constipation - follow-up of patients from the pivotal studies. Aliment Pharmacol Ther. 2010 Nov;32(9):1113-23. doi: 10.1111/j.1365-2036.2010.04455.x. Epub 2010 Sep 16.

Results Reference

derived

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Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation

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